Amendments to proposed EU clinical trials regulation could have significant impact *

European Union - February 20 2013
Recently published amendments prepared by the Rapporteur of the European Parliament's responsible committee on the Commission's proposal to reform…

Co-authors: Maarten Meulenbelt, Scott Bass, James C. Stansel, Vincenzo Salvatore, Mike W. J. Beckers.

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EU continues revision and implementation of strict GMP rules *

European Union - February 4 2013
In January 2013, three important developments regarding the EU's good manufacturing practice ("GMP") rules for medicinal products were made public:…

Co-authors: Maarten Meulenbelt, Vincenzo Salvatore.

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Amendments to proposed EU Data Protection Regulation raise concerns in global life sciences industry *

European Union - January 29 2013
The European Parliament's Civil Liberties Committee has published its draft report on the proposed EU Data Protection Regulation which will have a…

Co-authors: Maarten Meulenbelt, Vincenzo Salvatore, William RM Long.

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European Commission publishes guidelines on use of food-related health claims *

European Union - January 28 2013
On 25 January 2013, the European Commission's new guidelines regarding the use of food-related health claims ("Guidelines") were published in the…

Co-authors: Maarten Meulenbelt, Vincenzo Salvatore.

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EU court rules on classification of certain borderline products as medical devices *

European Union - December 3 2012
In a judgment published on November 22, 2012, the Court of Justice of the European Union (CJEU) confirmed that products intended for the investigation of physiological processes only fall within the scope of the EU Medical Device Directive (93/42/EEC), as implemented into EU Member State legislation, if the products are intended for a medical purpose.

Co-authors: Maarten Meulenbelt, Scott Bass, James C. Stansel, Vincenzo Salvatore.

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